UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000008166 |
|---|---|
| Receipt number | R000009617 |
| Scientific Title | NOboRi biolimus A9-Eluting stent for right Coronary OstIum Lesion (NO RECOIL) registry |
| Date of disclosure of the study information | 2012/06/20 |
| Last modified on | 2012/06/14 07:29:38 |
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Basic information
Public title
NOboRi biolimus A9-Eluting stent for right Coronary OstIum Lesion (NO RECOIL) registry
Acronym
NO RECOIL registry
Scientific Title
NOboRi biolimus A9-Eluting stent for right Coronary OstIum Lesion (NO RECOIL) registry
Scientific Title:Acronym
NO RECOIL registry
Region
| Japan |
Condition
Condition
Angina pectoris
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy of NOBORI stent for right coronary artery ostial lesion
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
MACE (Cardiac death, Q-waveMI, Target lesion revascularization, Target vessel revascularization) at 12 month
Key secondary outcomes
1) Inhospital MACE
2) Cardiac death at 12 month
3) Myocardial infarction at 12 month
4) Target lesion revascularization at 12 month
5) Target vessel revascularization at 12 month
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
NOBORI Biolimus A9-eluting stent
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | < |
Age-upper limit
| 85 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1) Significant stenosi at right coronary artery ostial (within 10mm from ostial)
2) Vessel diameter > 2.5mm
3)
Key exclusion criteria
1) Right coronary artery in which other drug-eluting stent has been implanted.
2) Myocardial infarction within 7 days
3) Chronic total occlusion
4) Female with pregnant
5) Chronic renal failure (SCr.3.0)
6) Patients with malignant diseases
Target sample size
120
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yuji Oikawa and Shinichi Shirai |
Organization
The cardiovascular institute hospital
Kokura memorial hospital
Division name
Cardiology
Zip code
Address
3-2-19 Nishiazabu, Minato-ku, Tokyo, Japan
TEL
+81334082159
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kenya Nasu |
Organization
Toyohashi Heart Center
Division name
Cardiology
Zip code
Address
21-1 Gobutori, O-yama cho, Toyohashi, Aichi, Japan
TEL
+81532-37-3377
Homepage URL
yuyatomoya@gmail.com
Sponsor or person
Institute
The society of lipid lowering therapy
Institute
Department
Personal name
Funding Source
Organization
The society of lipid lowering therapy
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Toyohashi Heart Center (Aichi)
Kokura Memorial Hospital (Fukuoka)
The cardiovascular institute hospital (Tokyo)
Engaru Kosei hospital (Hokkaido)
Ayase Cardiovascular hospital (Tokyo)
Matsumoto Kyoritu Hospital (Nagano)
Hoshi general hospital (Fukushima)
Rinku general hospital (Osaka)
Other administrative information
Date of disclosure of the study information
| 2012 | Year | 06 | Month | 20 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Open public recruiting
Date of protocol fixation
| 2011 | Year | 08 | Month | 30 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2012 | Year | 12 | Month | 01 | Day |
Date of closure to data entry
| 2013 | Year | 12 | Month | 01 | Day |
Date trial data considered complete
| 2013 | Year | 12 | Month | 01 | Day |
Date analysis concluded
| 2014 | Year | 06 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2012 | Year | 06 | Month | 14 | Day |
Last modified on
| 2012 | Year | 06 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009617
